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510(k) Data Aggregation
(148 days)
The Elecsys proBNP II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalCheck 5 is a lyophilized product consisting of NT-proBNP (1-76) amide, human serum and a potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided submission discusses the Elecsys proBNP II CalCheck 5, a control product for immunoassay analyzers. As a control material and not a diagnostic device, the acceptance criteria and study detailed below focus on its performance as such.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | The CalCheck 5 levels must be accurately assigned. | Not explicitly detailed in the provided text, but implied by the "value assignment" evaluation. The device is expected to provide accurate control values for verification purposes. |
| Stability | The CalCheck 5 must maintain its specified range of values under various storage and handling conditions (unopened and reconstituted). | Unopened: Store at 2-8°C until expiration date. (Performance matches predicate) |
| Reconstituted: 4 hours at 20-25°C. (Performance matches predicate) | ||
| Intended Use | The device must function as an assayed control for calibration verification and assay range verification for Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers. | The intended use is clearly stated and aligns with the device's function. The study implies successful verification of this claim. |
| Equivalency to Predicate | The Elecsys proBNP II CalCheck 5 must be substantially equivalent to the currently marketed Elecsys proBNP II CalCheck (K080147) in terms of characteristics and performance. | The submission directly states: "The Elecsys proBNP II CalCheck 5 was evaluated for value assignment and stability," and then states that the performance characteristics (format, handling, stability, matrix, buffer) are "Same" as the predicate, except for the number of levels (5 vs 3). This indicates equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a patient cohort. For a control material, the "test set" would primarily involve multiple batches or samples of the control material tested across various instruments and conditions. The sample size for these evaluations (value assignment and stability studies) is not explicitly stated in the provided text.
The data provenance is also not explicitly stated beyond being part of a regulatory submission from Roche Diagnostics, indicating it would be internally generated data from their manufacturing and testing facilities. It would be considered prospective for the purposes of the submission, as the studies would have been conducted specifically to support the 510(k) application for the new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a control material, the "ground truth" for its value is established through rigorous internal validation processes by the manufacturer, typically involving highly accurate reference methods and multiple expert analytical chemists or laboratory scientists. The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., the assigned values) for the Elecsys proBNP II CalCheck 5. This information is typically part of the internal quality control and manufacturing documentation, not necessarily detailed in a 510(k) summary for a Class I device.
4. Adjudication Method for the Test Set
Given the nature of a control material and the type of evaluation described ("value assignment and stability"), a formal "adjudication method" involving multiple human readers or reviewers of subjective data (like image interpretation) is not applicable. The "adjudication" in this context would be the internal quality control and statistical analysis methods used by Roche to determine the consensus assigned values and stability profiles, which are objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often in conjunction with AI. The Elecsys proBNP II CalCheck 5 is a laboratory control material, not an AI-powered diagnostic device, and its use does not involve human readers interpreting complex medical cases or images.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The Elecsys proBNP II CalCheck 5 is a physical chemical control product, not a software algorithm or AI. Therefore, the concept of "algorithm only" performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys proBNP II CalCheck 5 refers to the assigned concentration values of NT-proBNP in each of the five levels. This ground truth is established through:
- Analytical measurement and calibration: Using highly accurate reference methods and calibrated instruments to determine the precise concentration of the analyte (NT-proBNP) spiked into the matrix during manufacturing.
- Manufacturer's internal validation: Rigorous testing and statistical analysis conducted by Roche Diagnostics to ensure the assigned values are accurate and reproducible.
It is not based on expert consensus of clinical images, pathology (histology), or patient outcomes data, as these are not relevant to the function of a laboratory control.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. The Elecsys proBNP II CalCheck 5 is a manufactured control material, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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